WASHINGTON -- While generally supportive of a risk-based approach taken by the Food and Drug Administration in connection with a set of regulations proposed in connection with the Food Safety Modernization Act, the American Bakers Association urged the agency to keep its guidance “as simple as possible.”

The comments by Lee Sanders, A.B.A. senior vice-president of government relations and public affairs, were submitted Nov. 15 in response to a request for comments in connection with a rulemaking proposal by the F.D.A. published in the Jan. 16 Federal Register. “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” was proposed by the F.D.A. as an update of its existing good manufacturing practice regulations.

In addition to asking the F.D.A. to “keep it simple,” Ms. Sanders in a 20-page letter reviewed a number of aspects of the regulations, endorsing some and offering guidance about others. Simplicity will allow companies to design programs suited for particular facilities and product lines, she said.

“A.B.A. applauds the risk-based approach that F.D.A. has taken in proposing to implement section 418 and the agency's recognition that a ‘one-size-fits-all’ approach is not appropriate with respect to hazard analysis and preventive controls,” she said. “We urge F.D.A. to retain that flexibility in the final rule and to consider the recommendations for clarification presented in our comments above. We ask F.D.A. to keep any guidance as simple as possible to allow for flexible design of programs that are optimal for a specific manufacturing facility and line of product being produced. Finally, once a final rule is published, A.B.A. urges F.D.A. to ensure that its inspectors are appropriately trained not only on the requirements of that rule, but also on the fact that the rule allows facilities the flexibility to determine the best approach through which they may satisfy the regulatory requirements.”

In its January proposal, the F.D.A. said the new rule would add preventive controls provisions required in the Food Safety Modernization Act requiring that covered facilities maintain a food safety plan, perform hazard analysis and institute preventive controls “for the mitigation of those hazards.” The F.D.A. said facilities also would need to monitor controls, verify their effectiveness, apply corrective actions when needed and maintain documentation of these actions. Additionally, the F.D.A. described the new rule as an update of its G.M.P. regulations, last revised more than 25 years ago.

More specifically, the rule would establish requirements for:

- A written food safety plan;

- Hazard analysis;

- Preventive controls for hazards that are reasonably likely to occur;

- Monitoring;

- Corrective actions;

- Verification; and

- Associated records.

“The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur,” the F.D.A. said.

- Supporting a flexible, risk-based approach: Ms. Sanders expressed A.B.A. appreciation for the recognition in the rule of “the importance and health benefits of a risk-based approach to public safety, in which industry and agency resources are targeted toward known or reasonably foreseeable risks.” More specifically, she noted the proposal requires preventive controls only for “hazards reasonably likely to occur.” She said that language here and later in the rules is not intended to be speculative but is based on history and experience that reveals a genuine food safety risk.

- Exemption for packaged foods storage facilities: An issue that long has been a concern of the A.B.A. and other packaged foods companies (a citizen’s petition on the issue was submitted by industry groups), Ms. Sanders said the baking industry strongly supports an exemption. With the exemption, the storage facilities would be required to conduct other activities for “packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public health significance.”

- Product testing should not be required: The F.D.A. proposal does not require testing of finished product, and the A.B.A. agrees, Ms. Sanders said. She noted finished product is “likely of limited or no value because a facility cannot test each and every food product to guarantee safety.” She continues, “Testing only demonstrates that the sample taken was pathogen free; it cannot verify that the entire lot is pathogen free.”

- Monitoring of customer complaints should not be required: Ms. Sanders said each verification activity specified in F.S.M.A. has a “sound scientific basis” aimed at enhancing food safety. Reviewing customer complaints has no such basis, she said. “The overwhelming majority of these inquiries involve issues that are wholly unrelated to food safety such as questions about pricing, availability, promotions and packaging (e.g., difficulty opening the product),” she said. Ms. Sanders said bakers rarely first identify food safety issues through customer complaints.

- Opposing requirements to validate allergen controls: While declaring that the A.B.A. and its members are committed to reducing the possibility of allergen cross-contact in baking facilities and the appearance of undeclared allergens in baked foods, Ms. Sanders said monitoring that labels are correct rather than validation is the appropriate approach for this issue.

- Issues related to records and information: Noting there is no evidence of shortcomings in the recordkeeping of food facilities, Ms. Sanders said, “A.B.A. agrees that it is important for records to be reliable and secure, and A.B.A. supports an approach to encourage electronic recordkeeping, the application of Part 11 appears excessive.” The letter notes Part 11 includes controls applicable to electronic documents with the objective to “ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine.” She noted the F.D.A., responding to industry concerns, said it would “exercise enforcement discretion with respect to controls related to validation, audit trails, record retention, record copying and inspection, and legacy systems, as the agency reexamines Part 11.”

- Providing a facility profile: The F.D.A. is seeking a limited collection of facility profile information with the expectation it will help targeting inspections to facilities that handle certain kinds of foods or have inadequate controls. “The A.B.A. urges F.D.A. not to require facilities to submit a facility profile. Information regarding hazards and preventive controls are best assessed in the context of a full food safety plan, related documentation, and interviews with personnel,” Ms. Sanders said. “This information does not lend itself to summary data that can be sorted, searched, and analyzed in a meaningful way.”

- Research and development facilities: While many baking industry r.&d. facilities do not produce food that is consumed (and are not required to register with the F.D.A.), others make test samples  that are consumed, Ms. Sanders said. The amounts produced are “minimal” and do not enter in interstate commerce. The amount produced is “limited to that necessary to determine if produce concepts and/or product adjustments meet specific objectives related to product quality and acceptance.” The letter continued, “The F.D.A. has the discretion not to require compliance with the preventive controls requirements of section 418 of F.S.M.A., A.B.A. urges the agency to exercise its enforcement  discretion and not require baking industry R. and D. facilities to comply with subpart C of the proposed rule.”

- Qualified individual: Ms. Sanders said the A.B.A. agrees with the F.D.A. that a qualified individual should be responsible for the preparation of the food safety plan, validate preventive controls and the appropriateness of corrective actions and reanalyze a food safety plan. While also agreeing that the responsible party should be trained properly or have enough experience, the A.B.A. urged that F.D.A. “not get involved directly in developing a certification process but rather support competent third parties in developing and implementing a process.”